Boston Scientific recalled 32,695 pacemakers on August 20, 2025. The recall affects multiple models due to software that may prevent initiation of Safety Mode. This defect poses a high hazard level to patients who rely on these devices.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
The recall includes ACCOLADE DR SL (Model L301) and other models from the ACCOLADE family. These devices were distributed worldwide, with a total of 32,695 units recalled.
The software issue may prevent the pacemakers from entering Safety Mode during high battery impedance conditions. This can lead to serious health risks for patients relying on these devices.
No specific incidents or injuries have been reported related to this recall. However, the potential for serious health implications is significant.
Patients and healthcare providers should stop using the affected devices immediately. Contact Boston Scientific Corporation or a healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0080-2026.
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